Example: Bundle - Manufacturing, substance - Pharmaceutical Quality (Industry) v1.0.0

Pharmaceutical Quality (Industry)
1.0.0 - STU1 International flag

Pharmaceutical Quality (Industry), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/uv-dx-pq/ and changes regularly. See the Directory of published versions

Example Bundle: Example: Bundle - Manufacturing, substance

Bundle bundle-product-manufacturing-pq-ex2-sub of type collection

Entry 1 - fullUrl = urn:uuid:bf6b038b-1334-3dd4-a552-65c169e2265a

Resource PlanDefinition:

Generated Narrative: PlanDefinition
Resource PlanDefinition "manufacturingProcess-unlinked"
Extension - Plan Document Reference PQ: See on this page: DocumentReference/74d4c070-6596-8252-8ad9-afa515a41feb
Extension - History of Process PQ: This can be text about the history
url: http://example-server.com/fhir/PlanDefinition/bf6b038b-1334-3dd4-a552-65c169e2265a
type: Manufacturing Process (Pharmaceutical Plan Type Codes#manufacturing-process)
status: ACTIVE
subject: See on this page: SubstanceDefinition/c458791f-7cb8-428e-83f7-8a205f821152
description: Narrative description of substance manufacturing process
goal
id
goal-control-pH
category: Physical Property (Pharmaceutical Test Category Codes#C123456)
description: Controls - pH ()
priority: Critical (Goal Priority - example#critical)
Targets
- Measure Detail[x]
* Long description of the acceptance criteria - pH must be in range 6.9 to 7.1 (Example Local Codes - Drug#pH "pH") 6.9-7.1 pH
goal
id
goal-control-temp
category: Physical Property (Pharmaceutical Test Category Codes#C123456)
description: Controls - Temperature ()
priority: Non-critical (Goal Priority - example#non-critical)
Targets
- Measure Detail[x]
* Long description of the control value - Temperature must be below 150°C (Example Local Codes - Drug#TEMP "Temperature") ?-150
action
code: overall process (Manufacturing Step Codes#overall process "Overall Process")
action
Extension - Process Step Scale PQ: Production Scale (Details: http://terminology.hl7.org/CodeSystem/manufacturing-step-scale code PROD = 'Production Scale', stated as 'Production Scale')
Extension - Process Parameters PQ
url
parameter
value: Mix speed (Process Parameter Codes#SPEED)
url
value
value: 1500 rpm

Entry 2 - fullUrl = urn:uuid:82a39a18-91cf-a19d-76c1-a9e8bad9494c

Resource DeviceDefinition:

Generated Narrative: DeviceDefinition
Resource DeviceDefinition "82a39a18-91cf-a19d-76c1-a9e8bad9494c"
DeviceNames
- Name Type
* Rotating Impeller with 1.5mm screen REGISTEREDNAME
Properties
- Type Value[x]
* Maximum Speed (Device Property Codes#Maximum Speed) 5000 RPM

Entry 3 - fullUrl = urn:uuid:74d4c070-6596-8252-8ad9-afa515a41feb

Resource DocumentReference:

Generated Narrative: DocumentReference
Resource DocumentReference "74d4c070-6596-8252-8ad9-afa515a41feb" Version "1" Updated "2023-01-12 17:57:08+0000"
Information Source: #n4xHiP0iat7deVDt!
identifier: http://example.org/fhir/identifier/document/FLOW-001
status: CURRENT
type: Process Flow Diagram (Diagram Type Codes#ProcessFlowDiagram)
content
Attachments
- Url
* https://example.org/docStore/flow-001

Entry 4 - fullUrl = urn:uuid:74d4c070-6596-8252-8ad9-afa515a41fef

Resource DocumentReference:

Generated Narrative: DocumentReference
Resource DocumentReference "74d4c070-6596-8252-8ad9-afa515a41fef"
status: CURRENT
content
Attachments
- Url
* https://www.accumulus.org/wp-content/uploads/2022/05/Accumulus_Logo_horizontal.png

Entry 5 - fullUrl = urn:uuid:c458791f-7cb8-428e-83f7-8a205f821152

Resource SubstanceDefinition:

Generated Narrative: SubstanceDefinition
Resource SubstanceDefinition "c458791f-7cb8-428e-83f7-8a205f821152"
manufacturer: See on this page: Organization/9fe98cfa-9245-8313-0fc5-d15e613b5d6d
Names
- Name
* Stelbatolol

Entry 6 - fullUrl = urn:uuid:9fe98cfa-9245-8313-0fc5-d15e613b5d6d

Resource Organization:

Generated Narrative: Organization
Resource Organization "9fe98cfa-9245-8313-0fc5-d15e613b5d6d"
identifier: urn:oid:2.16.840.1.113883.4.82/3003040516
active: true
type: Drug Substance Manufacture (Pharmaceutical Organization Type Codes#drug-substance-manufacture)
name: AAA Molybdenum Products, Inc.
Contacts
- Address
* 7233 W 116th Pl Ste C Broomfield Colorado 80020 USA

Entry 7 - fullUrl = urn:uuid:c458791f-7cb8-428e-83f7-8a205f821153

Resource SubstanceDefinition:

Generated Narrative: SubstanceDefinition
Resource SubstanceDefinition "c458791f-7cb8-428e-83f7-8a205f821153"
manufacturer: See on this page: Organization/9fe98cfa-9245-8313-0fc5-d15e613b5d6d
Names
- Name
* Stelbatosubstance

Entry 8 - fullUrl = urn:uuid:c458791f-7cb8-428e-83f7-8a205f821154

Resource SubstanceDefinition:

Generated Narrative: SubstanceDefinition
Resource SubstanceDefinition "c458791f-7cb8-428e-83f7-8a205f821154"
Names
- Name
* Resultothane

Entry 9 - fullUrl = urn:uuid:c458791f-7cb8-428e-83f7-8a205f821155

Resource SubstanceDefinition:

Generated Narrative: SubstanceDefinition
Resource SubstanceDefinition "c458791f-7cb8-428e-83f7-8a205f821155"
manufacturer: See on this page: Organization/9fe98cfa-9245-8313-0fc5-d15e613b5d6d
Names
- Name
* Processohol

IG © HL7 International / Biomedical Research and Regulation. Package hl7.fhir.uv.pharm-quality#1.0.0 based on FHIR 5.0.0. Generated 2024-05-08
Links: Table of Contents | QA Report | Version History | | Propose a change